EXHIBIT 10.14
Confidential
RESEARCH AND DEVELOPMENT AGREEMENT
BETWEEN
Chemokine Therapeutics Corp.
0000 Xxxx Xxxx
Xxxxx 000
Xxxxxxxxx, X.X.
X0X 0X0
Xxxxxx
AND
Procter & Xxxxxx Pharmaceuticals, Inc.
0000 Xxxxx-Xxxxxxxxxx Xxxx
Xxxxx,
XX 00000-0000
XXX
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED
PROVISIONS OF THIS AGREEMENT. THE REDACTED PROVISIONS ARE INDICATED BY
THREE ASTERISKS ENCLOSED BY BRACKETS AND UNDERLINED. THE CONFIDENTIAL
PORTIONS HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
WHEREAS:
1. Chemokine Therapeutics, Corp. (hereinafter "CTC") has:
a. Proprietary rights and know-how to certain chemokine analogs,
including chemokine stromal cell derived factor 1 (SDF-1) and
chemokine interleukin 8 (IL-8) analogs as well as other
potential chemokine products (agonists and antagonists) that
appear to have efficacy in a range of areas including, but not
limited to the development of cardiac muscle and vascular
tissues, collectively categorized as neovascularization.
b. Strong molecular creation, development, and manufacturing
capabilities in the field of peptides and the design of
chemokine-based products.
c. An affiliated subsidiary company called Globe Laboratories
Inc. ("Globe Laboratories") which is involved in peptide and
protein manufacturing.
2. Procter & Xxxxxx Pharmaceuticals (hereinafter "PGP") has:
a. A research and development program directed toward therapeutic
applications for vascular and cardiovascular disease
management.
b. Capabilities in testing and validation of new therapeutic
approaches for vascular and cardiovascular disease.
c. A desire to evaluate analogs of chemokine stromal cell derived
factor 1 (SDF-1 analogs).
d. An interest in requesting CTC to create new mimetics of yet to
be determined chemokine molecules.
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NOW THEREFORE, CTC and PGP in consideration of the mutual covenants contained
herein agree as follows:
1 DEFINITIONS IN THIS AGREEMENT
1.1 "Agreement" shall mean this Agreement, the recitals herein and the
Appendices A, B, and C hereto.
1.2 "Collaboration Compound" shall mean a non-CTC Compound and not
covered in any CTC patents which is discovered or developed jointly
during the Study or Reporting periods of this Agreement and jointly
owned by CTC and PGP equally.
1.3 "Confidential Information" shall mean Information pursuant to
Section 1.9, which the disclosing Party indicates is confidential.
Confidential Information shall be so marked when disclosed in
writing or shall be reduced to writing and be so marked within
thirty (30) days after disclosure if disclosed by any means other
than writing.
1.4 "CTC Affiliated Company" shall be Globe Laboratories Inc.
1.5 "CTC Compounds" shall mean the compounds described in Appendix A
hereto.
1.6 "Data" shall mean the measurements, results, and information whether
electronic or hardcopy, developed by PGP in the execution of the
Study Plans and solely related to the CTC Compounds.
1.7 "Effective Date" shall be the last date of execution of this
Agreement.
1.8 "Field" shall mean the development of therapeutic drugs for vascular
and cardiovascular disease, and cardiac muscle regeneration
including neovascularization.
1.9 "Information" shall mean any information, data, or materials, in
whatever form disclosed by a Party to the other Party under this
Agreement including without limitation all scientific, pre-clinical,
clinical, regulatory, manufacturing, marketing, financial and
commercial information or data, non-limiting examples of which
include: amino acid or nucleic acid sequences, plasmids, vectors,
expression systems, cells, cell lines, antibodies, biological
substances, and constituents, progeny, mutants, derivatives or
replications thereof or there from, together with all reagents,
chemical compounds or other material, data, information about
methods of operation, processes, formulations, technical
information, equipment or apparatus, memoranda or reports, know-how,
clinical reports, patent prosecution status and strategy, business
plans, cost, sales and research or marketing developments.
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1.10 "Option" shall mean the right to negotiate an exclusive license, as
per Appendix C of this Agreement, on CTC Compounds for further
development in the Field.
1.11 "Option Period" shall mean the period of sixty (60) days after the
thirty (30) days Reporting Period.
1.12 "Party" or "Parties" shall mean CTC or PGP individually or CTC and
PGP jointly, as the context requires.
1.13 "Report" shall mean the report to be delivered by PGP to CTC thirty
(30) days after the Study Period.
1.14 "Reporting Period" shall mean thirty (30) days after the Study
Period.
1.15 "Services" shall be the work done by PGP during the Study Period of
this Agreement.
1.16 "Study Period" shall be nine (9) months.
1.17 "Study Plans" shall mean the individual plan or the two plans
together mutually agreed upon by the Parties for the evaluation of
CTC Compounds. The Study Plans are attached as Appendix B.
2 EXCLUSIVE RESEARCH PROGRAM
2.1 CTC grants to PGP an exclusive research opportunity to evaluate the
CTC Compounds in the Field, in Ex vivo and In vivo evaluations
conducted in accordance with the Study Plans. This exclusive
research opportunity shall comprise two distinct periods, as
follows:
2.1.1 Study Period:
PGP shall have an exclusive opportunity to evaluate any or all
of the CTC Compounds in Ex vivo and In vivo models of
cardiovascular disease in accordance with the Study Plans. The
Study Period will commence on the Effective Date, but the
commencement of the Study Period will be extended on a
day-for-day basis until CTC provides to PGP a sufficient
amount (as contemplated in the Study Plans and Paragraph 2.3
of this Agreement) of all of the CTC Compounds to enable PGP
to commence the evaluation.
2.1.2 Reporting period:
Upon completion by PGP of the Study Period conducted in
accordance with the Study Plans, PGP shall prepare, and
deliver to CTC within thirty (30) days, a detailed Report on
the results of the evaluations conducted in accordance with
the Study Plans,
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including all data, analysis, and conclusions drawn by PGP in
relation to such evaluations.
2.2 In consideration of the exclusive research opportunity granted to
PGP by CTC, and in consideration of the exclusive option to license
contemplated in Paragraph 3 of this Agreement, PGP shall pay to CTC
or to the CTC Affiliated Company the following amounts:
a) the amount of two-hundred seventy five thousand ($275,000.00)
United States dollars within forty five (45) days of the
Effective Date of this Agreement and subject to Section 2.2
(c); and
b) an additional one hundred thousand ($100,000.00) United States
dollars at the beginning of any and all subsequent three (3)
month periods, subject to a request for extension of the Study
Period in writing by PGP; and
c) payments will be made by PGP within forty five (45) days of
receipt by the PGP Accounts Payable department of an invoice
from CTC, subject to registration of vendor data by CTC and
CTC Affiliated Company with PGP. Invoices must include the
purchase order number assigned by PGP, vendor registration
number and should be sent to Accounts Payable, Procter &
Xxxxxx, X.X. Xxx 0000, Xxxxxxxxxx, Xxxx 00000-0000.
2.3 To facilitate PGP's evaluation of the CTC Compounds during the Study
Period, CTC shall provide CTC Compounds to PGP on the following
terms:
a) During the Study Period, CTC shall provide to PGP up to ten
(10) milligrams (mg) of any or all of the CTC Compounds at no
charge for Ex vivo testing. CTC and PGP agree that a
sufficient amount of CTC Compounds to enable PGP to commence
the Ex vivo evaluation is no more than ten (10) milligrams
(mg) of each of the CTC Compounds. Additional quantities of
CTC Compounds for use in the Ex vivo evaluation shall be made
available by CTC to PGP upon request and payment to CTC of
CTC's manufacturing costs, plus labour calculated at one
hundred fifty ($150.00) United States dollars per hour.
b) During the Study Period, CTC shall provide to PGP up to two
hundred fifty (250) milligrams (mg) of any or all of the CTC
Compounds at no charge for In vivo testing. CTC and PGP agree
that a sufficient amount of CTC Compounds to enable PGP to
commence the In vivo evaluation is no more than two hundred
fifty (250) milligrams (mg) of each of the CTC Compounds.
Additional quantities of CTC Compounds for use in the In vivo
evaluation shall be made available by CTC to PGP upon request
and payment to CTC of CTC's manufacturing costs, plus labour
calculated at one
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hundred fifty ($150.00) United States dollars per hour.
c) Upon conclusion of the exclusive research opportunity, PGP
shall return to CTC any unused quantities of CTC Compounds.
2.4 CTC and PGP shall collaborate and share Confidential Information and
Data during the Study and Reporting Periods of the exclusive
research opportunity, as may be necessary to facilitate the
execution and analysis of the Study Plans. Permitted uses and
ownership of any Collaboration Compound or other jointly-developed
intellectual property that may arise from any such collaboration
during the Study and Reporting Periods of the exclusive research
opportunity are dealt with in Paragraph 5 of this Agreement.
2.5 For the purpose of this Agreement payments as per clauses 2.2 and
2.3 should be paid to CTC Affiliated Company (Globe Laboratories)
and future Milestones and Royalties as per Appendix C shall be paid
to CTC.
3. EXCLUSIVE OPTION TO LICENSE
3.1 Upon conclusion of the exclusive research program, PGP shall have
sixty (60) days ("Option Period"), calculated from the date of
receipt by CTC of the Report contemplated in Paragraph 2.1.2 of this
Agreement, within which to seek and conclude an exclusive license
agreement with CTC relating to the further development and
commercialization of one of the CTC Compounds. This time limit may
be extended by a further sixty (60) days upon consent by CTC.
3.2 If PGP does seek an exclusive license in relation to the further
development and commercialization of any one of the CTC Compounds,
CTC and PGP agree to use their best efforts to negotiate and
conclude a license agreement that reflects the Heads of Agreement
set out in "Appendix C". Separate exclusive license agreements will
be required in relation to each CTC Compound if PGP seeks licenses
in relation to the further development and commercialization of more
than one of the CTC Compounds. The terms of the license agreement
for additional compounds will be negotiated between CTC and PGP at
the later stage.
3.3 If PGP does not seek an exclusive license from CTC within the Option
Period defined in Paragraph 3.1, then the Report contemplated in
Paragraph 2.1.2 of this Agreement, the Data, and any Confidential
Information both generated by and shared between CTC and PGP during
the Study and Reporting Periods of the exclusive research
opportunity, shall to the extent such Report, Data and Confidential
Information directly relate to the CTC Compounds, be owned solely by
CTC. Permitted uses and ownership of any Collaboration Compound or
other jointly-developed intellectual property that may arise from
any collaboration during the Study and Reporting Periods of the
exclusive research opportunity are dealt with
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in Paragraphs 5.3 of this Agreement. Nothing in this Section 3.3
shall be construed to reduce the rights and protections of PGP or
relieve the obligations of CTC with respect to Confidential
Information disclosed by PGP to CTC, pursuant to Section 4.
4 CONFIDENTIALITY
4.1 In preparation of and during the course of the Project, it may be
necessary for a Party to disclose Confidential Information to the
other Party. The Parties agree that all Confidential Information
disclosed to one Party by the other Party for the purposes of this
Agreement (1) are to be received in strict confidence, (2) are to be
used only for the purposes of this Agreement, and (3) are not to be
disclosed by the recipient party, its agents, employees or assigns
without the prior written consent of the other Party, except to the
extent that such information, as established by relevant documentary
evidence:
4.1.1 was in the public domain at the time of disclosure;
4.1.2 later became part of the public domain through no act or
omission of the recipient Party, its employees, agents,
successors or assigns;
4.1.3 was lawfully disclosed to the recipient Party by a third party
having the right to disclose it;
4.1.4 was already known by the recipient Party at the time of
disclosure;
4.1.5 was independently developed by the recipient; or
4.1.6 is required by law or regulation to be disclosed, provided
however, that the Party being obliged to disclose shall first
give the other Party written notice and adequate opportunity
to object to such order for disclosure or to request
confidential treatment.
4.2 Confidential Information shall not be deemed to be available to the
public or to be in the recipient's possession merely because it:
4.2.1 includes information that falls within an area of general
knowledge available to the public or to the recipient (i.e.,
it does not include the specific information provided by the
other Party); or
4.2.2 can be reconstructed in hindsight from a combination of
information from multiple sources that are available to the
public or to the recipient, if not one of those sources
actually taught or suggested the entire combination, together
with its meaning and importance.
4.3 Each Party's obligation of confidence hereunder shall be fulfilled
by using at least the same degree of care with the other Party's
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Confidential Information as it uses to protect its own Confidential
Information. This obligation shall exist while this Agreement is in
force and for a period of five (5) years thereafter.
5 INTELLECTUAL PROPERTY RIGHTS
5.1 All rights to the Data and Confidential Information generated by PGP
shall be exclusively owned by PGP.
5.2 Notwithstanding 5.1, termination of the Agreement by PGP pursuant to
6.6 or PGP decision to not negotiate or exercise a license agreement
during the Option Period, then all rights to the Data will transfer
to CTC.
5.3 Subject to 5.2, CTC shall have the exclusive right to file patent
applications on CTC Compounds utilizing the Data and all inventions
made solely by CTC personnel. If CTC decides not to file a patent
application on an invention made under the Study Plans, and PGP
wishes to file a patent application on such invention, then PGP
shall have the right to file such patent, after written approval is
obtained from CTC, such approval not to be unreasonably withheld. In
the latter case, PGP shall be the sole owner and beneficiary of such
patent. Inventions created hereunder jointly by CTC and PGP, even if
not solely related to CTC Compounds, shall be owned equally by CTC
and PGP ("Joint Inventions"). If either CTC or PGP desires that a
patent covering such Joint Inventions be obtained, they will
determine and agree as to whether CTC or PGP will be responsible for
preparation, filing and prosecution of patent applications; the
other Party shall provide full cooperation for such efforts.
Inventions made solely by PGP personnel and unrelated to CTC
Compounds shall be owned by PGP.
6 TERM AND TERMINATION
6.1 The Agreement will become effective on the Effective Date.
6.2 The term of this Agreement shall be twelve (12) months from the
receipt of CTC Compounds unless extended by mutual agreement of the
Parties or terminated earlier in accordance with the provisions of
this Agreement.
6.3 Either Party ("the Terminating Party") shall be entitled to
terminate this Agreement at any time by notice in writing to the
other Party ("the Defaulting Party") if the Defaulting Party is in
material breach of this Agreement which breach is irremediable or,
if remediable, is not remedied by the defaulting Party within thirty
(30) days of being requested to do so by the other.
6.3.1 If the Defaulting Party is PGP and PGP fails to remedy the
material breach, then CTC shall own the Data and the exclusive
opportunity granted to PGP under Section 2.1 shall be
terminated.
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6.3.2 If the Defaulting Party is CTC and CTC fails to remedy the
material breach, then PGP shall own the Data.
6.4 Either Party shall have the right to terminate the Agreement in case
of bankruptcy or insolvency of the other Party.
6.5 The Parties shall have the right to terminate the Agreement at any
time by mutual written agreement of both Parties and subject to any
terms herein which survive termination.
6.6 PGP retains the right to terminate the Agreement at any time upon
thirty (30) days written notice to CTC and subject to any terms
herein which survive termination.
6.7 Termination or expiration of this Agreement by a Party for any
reason shall not affect the rights and obligations of the Parties
accrued prior to the date of termination or expiration of this
Agreement.
6.8 No termination or expiration of this Agreement shall release the
Parties from their rights and obligations under the Articles 4, 5,
7, and 10.
7 PUBLIC ANNOUNCEMENTS
7.1 Neither Party shall use the name of the other Party or of any member
of the other Party's staff, in any publicity, advertising, news
release or otherwise disclose the existence of this Agreement or the
transactions contemplated hereby, unless required by law, without
the prior written approval of an authorized representative of the
other Party involved. Such written approval will not be unreasonably
withheld or delayed.
8 NOTICES
8.1 Any notices required to be given under this Agreement shall be in
writing and shall be deemed duly served if hand delivered or sent by
facsimile or by mail correctly addressed to the relevant Party's
address as specified in Article 8.3. of this Agreement or at such
other address as such Party may designate from time to time in
writing in accordance with this clause. Any notice sent by mail
shall be sent by registered mail and any notice sent by facsimile or
telex shall be confirmed by registered mail.
8.2 Any notice shall be deemed to have been served:
8.2.1 if hand delivered, at the time of delivery;
8.2.2 if sent by facsimile, eight (8) hours after the transmission
during normal business hours or, if transmission is not during
normal business hours, at the start of the normal business
hours on the next following day (exclusive of Saturdays,
Sundays and public holidays), but subject to production by the
sender of confirmation
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from the transmitting facsimile machine that a satisfactory
transmission has been completed;
8.2.3 if sent by mail, five (5) working days after mailing exclusive
of Saturdays, Sundays and public holidays.
NOTIFICATIONS SHALL BE SENT TO:
For CTC For Globe Laboratories
Xxxxx Xxxx, MBA, CFA
Chief Financial Officer Xxxxxx Xxx
Chemokine Therapeutics Corp. Controller
2386 East Mall Globe Laboratories, Inc.
Xxxxx 000 0000 Xxxx Xxxx
Xxxxxxxxx, XX Suite 208
V6T 1Z3 Xxxxxxxxx, XX
Xxxxxx X0X 0X0
Telephone: 000-000-0000 Canada
Facsimile: 000-000-0000 Telephone: 000-000-0000
Email: xxxxx@xxxxxxxxx.xxx Facsimile: 000-000-0000
For PGP
Xxx Xxxxx, Ph.X.
Xxxxxxx & Xxxxxx Pharmaceuticals
Health Care Research Center
Mail Drop 1133
0000 Xxxxx-Xxxxxxxxxx Xxxx
Xxxxx, Xxxx, XXX 00000-0000
Telephone: 000-000-0000
Facsimile: 000-000-0000
Email: xxxxx.xx@xx.xxx
9 LIMITED WARRANTY
9.1 Except as otherwise set forth herein, the Parties disclaim and
exclude all other warranties or representations, express, implied or
statutory, with respect to the CTC Compounds, or the Services
provided for hereunder, including the implied warranties of
merchantability, fitness for a particular purpose and
non-infringement of a patent, trademark or other intellectual
property right.
10 INDEMNIFICATION
10.1 PGP shall indemnify, defend and hold harmless CTC and its directors,
officers, employees, and agents, and their successors, heirs, and
assigns (the "CTC Indemnitees") from and against liability, damage,
loss or expense (including reasonable attorneys' fees and expenses
of litigation) incurred by or imposed upon such CTC Indemnitees, or
any of them, in connection with any third party claims, suits,
actions, demands, or judgments, including, personal injury, death,
damage to real or personal
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property, and product liability, to extent arising directly out of:
(a) any actions or omissions of PGP under this Agreement; (b) any
material breach of this Agreement by PGP; or (c) the negligence,
gross negligence, or willful misconduct on the part of PGP; provided
however, that PGP shall make no such indemnity to the extent such
liability, damage, loss or expense is the result of CTC Indemnitees'
negligence, gross negligence, or willful misconduct, during the Term
of this Agreement.
10.2 CTC shall indemnify, defend and hold harmless PGP and its directors,
officers, employees, and agents, and their successors, heirs, and
assigns (the "PGP Indemnitees") from and against liability, damage,
loss or expense (including reasonable attorneys' fees and expenses
of litigation) incurred by or imposed upon such PGP Indemnitees, or
any of them, in connection with any third party claims, suits,
actions, demands, or judgments, including, personal injury, death,
damage to real or personal property, and product liability, to
extent arising directly out of: (a) any actions or omissions of CTC
under this Agreement; (b) any material breach of this Agreement by
CTC; or (c) the negligence, gross negligence, or willful misconduct
on the part of CTC; provided however, that CTC shall make no such
indemnity to the extent such liability, damage, loss or expense is
the result of PGP Indemnitees' negligence, gross negligence, or
willful misconduct, during the Term of this Agreement.
11 MISCELLANEOUS
11.1 This Agreement and its Appendices constitute the entire and only
agreement between the Parties with respect to its subject matter as
of the Effective Date and supersedes all prior agreements,
negotiations, representations and proposals, written or oral,
relating to its subject matter. No representation, undertaking or
promise shall be taken to have been given or be implied from
anything said or written in negotiations between the Parties prior
to this Agreement except as expressly stated in this Agreement.
11.2 If any provision, or part of any provision of this Agreement, or the
Appendices hereto, is invalidated by operation of law or otherwise,
that provision or part will to that extent be deemed omitted and the
remainder of this Agreement, or applicable attachment, will remain
in full force and effect. In place of any such invalid provision or
part thereof, the Parties undertake to agree on a similar but valid
provision the effect of which is as close as possible to that of the
invalid provision or part thereof.
11.3 No modification, amendment or waiver or any provision of this
Agreement shall be effective unless in writing, specifically
referring hereto and signed by both Parties.
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11.4 Failure of either Party to enforce at any time or for any period,
any right under this Agreement, does not constitute, and shall not
be construed as, a waiver of that right and shall not affect the
right later to enforce that right or any other right term herein
contained.
11.5 Neither Party may assign, subcontract, or delegate its rights and
obligations under this Agreement without the prior written consent
of the other Party. This Agreement shall be binding upon the
Parties, their successors and their permitted assigns.
11.6 Headings are included herein for convenience only and shall not be
used to construe this Agreement.
11.7 Neither Party shall be held liable or responsible to the other Party
nor deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party which
such Party could not reasonably be expected to have taken into
account at the execution of this Agreement, including, without
limitation, fires, floods, earthquakes, natural disasters,
embargoes, war, acts of war (whether war is declared or not), acts
of terrorism, insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts, omissions
or delays in acting by any governmental authority. Each Party shall
keep the other Party informed of any delays of such type and shall
use their reasonable efforts to minimize and mitigate the effect of
such delays. However, once such cause has been corrected or removed,
the Parties shall be held to their obligations hereunder with
respect to such failed or delayed performance.
11.8 Nothing in this Agreement and no action taken by the Parties
pursuant to this Agreement shall constitute or be deemed to
constitute a partnership between the Parties, or shall constitute
either Party as the agent, employee or representative of the other.
11.9 This Agreement may be executed in one or more counterparts and such
counterparts shall each be considered originals, and shall together
constitute one document.
11.10 All Parties must comply with all applicable national, state and
local laws and regulations in connection with its activities
pursuant to this Agreement.
11.11 This Agreement is governed in accordance with the laws of the United
States of America and of the State of Ohio.
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IN WITNESS WHEREOF the Parties have executed this Agreement as for the date last
set forth below:
PROCTER & XXXXXX PHARMACEUTICALS INC. CHEMOKINE THERAPEUTICS CORP.
/s/ Xxxxx Games /s/ Xxxxxx Xxxxxx
-------------------------------------- ------------------------------------
Name: Xxxxx X. Games, Ph.D. Name: Xxxxxx Xxxxxx, Ph.D.
Title: Vice President Title: Chairman & CEO
Global Pharmaceuticals
Date: Date:
-------------------------------- ------------------------------
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APPENDIX A
CTC COMPOUNDS
1) CTCE-0021 [***]*
Structure:
[***]*
2) CTCE-0029 [***]*
Structure:
[***]*
3) CTCE-0448 [***]*
Structure:
[***]*
4) CTCE-02111 [***]*
Structure:
[***]*
5) CTCE-02112 [***]*
Structure:
[***]*
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APPENDIX B
STUDY PLANS
[***]*
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APPENDIX C
HEADS OF AGREEMENT
Chemokine Therapeutics, Corp. and Procter & Xxxxxx Pharmaceuticals, Inc.
Heads of Agreement for License and Commercialization
Chemokine Therapeutics, Corp. (hereafter CTC) with its offices in Xxxxxxxxx,
Xxxxxxx Xxxxxxxx, Xxxxxx and Procter & Xxxxxx Pharmaceuticals, Inc. (hereafter
PGP) with its offices in Mason, Ohio, propose entering into a collaboration to
validate cardiovascular targets and active molecules that therapeutically affect
those targets. Within the collaboration, PGP will have an exclusive option to
take an exclusive license to further develop one (1) CTC compound and up to four
(4) back-up compounds for Further Development and Commercialization with the
goal for Commercialization of one compound. Commercialization of a second
compound by PGP will require a new and separate agreement.
Therefore, the Parties agree to the following terms as a basis for a license
agreement should PGP decide to exercise its option.
FIELD The Field shall be the development of therapeutic
drugs for vascular and cardiovascular disease, and
cardiac muscle regeneration including
neovascularization.
TERM The Term shall be the latter of expiration of
regulatory exclusivity in a Major Market Territory
covering a marketed Compound or expiration of patent
rights on a country-by-country basis; or early
termination as described in the Collaboration
Agreement.
TERRITORY The Territory shall be any territory worldwide.
MAJOR MARKET TERRITORY Major Market Territory includes the European Union
countries or any of the following countries: United
States, Canada, United Kingdom, France,
Germany, Italy, Spain, Australia, Brazil or Japan.
TECHNOLOGY The Technology shall be the assets provided by each
of the Parties to the collaboration and the results
of the work done by the Parties in the
collaboration as proposed in the work plan.
CTC COMPOUND A CTC Compound is a compound that is owned by CTC, or
CTC has exclusive worldwide license to the compound,
and is covered by the Agreement
COLLABORATION COMPOUND A Collaboration Compound is a compound not mentioned
in CTC patents to date, and will be developed jointly
during the Research Collaboration and is owned
jointly by CTC and PGP
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CURRENCY All currency quotations are in United States of
America (US) dollars (US$). "MM" is defined as US
million dollars (US$).
FURTHER DEVELOPMENT Preclinical research activities conducted in
preparation for filing of an IND
COMMERCIALIZATION Filing of a New Drug Application (NDA) for Regulatory
Approval by the FDA following the completion of
clinical trials.
LICENSE CTC will grant to PGP an exclusive License in the
Territory to the Technology for CTC Compounds during
the Term. CTC agrees that they will not compete or
enter into an agreement with a third party in the
Field and during the Term.
PATENT FILING PGP agrees to pay CTC all costs associated with
additional patent filings, including, but not limited
to, filings on the five compounds for therapeutic
angiogenesis. PGP may at its option, choose to
participate in writing the patents and defining the
claims.
R&D SUPPORT PGP will pay the direct and indirect costs for two
(2) full-time equivalent (FTE) CTC employees at an
agreed upon rate of [***]* ($[***]*) dollars per FTE
employee per annum from the date of execution of the
option through filing of the IND.
LICENSE FEE Upon execution of an Option for Compounds provided by
the Collaboration Agreement, PGP will pay to CTC a
License Fee in the amount of five hundred thousand
($[***]*) dollars.
MILESTONES PGP will pay to CTC Milestones for the following
events in the development of a CTC Compound:
Filing of an IND or equivalent $[***]*
Initiation of Phase II Study $[***]*
Initiation of Phase III Study $[***]*
Approval of NDA $[***]*
PGP will pay to CTC Milestones for the following
events in the development of a Collaboration
Compound:
Filing of an IND or equivalent $[***]*
Initiation of Phase II Study $[***]*
Initiation of Phase III Study $[***]*
Approval of NDA $[***]*
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29 June 2004
* PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
16
Confidential
TIERED ROYALTIES PGP will pay royalties to CTC for CTC Compounds according
to the following schedule for net sales in the Territory.
Net annual sales < $[***]* MM [***]*%
Net annual sales between $[***]*MM and $[***]*MM [***]*%
Net annual sales between $[***]*MM and $[***]*MM [***]*%
Net annual sales between $[***]*MM and $[***]*MM [***]*%
Net annual sales > $[***]*MM [***]*%
PGP will pay royalties to CTC for Collaboration
Compounds according to the following schedule for net
sales in the Territory.
Net annual sales < $[***]*MM [***]*%
Net annual sales between $[***]*MM and $[***]*MM [***]*%
Net annual sales between $[***]*MM and $[***]*MM [***]*%
Net annual sales between $[***]*MM and $[***]*MM [***]*%
Net annual sales > $[***]*MM [***]*%
THE FOLLOWING IS PROVIDED FOR PURPOSES OF A TIERED ROYALTY EXAMPLE ONLY. If Net
Annual Sales of a Collaboration Compound are $[***]*, then the royalty on those
sales would be $[***]* ($[***]* X [***]*%) plus $[***]* ($[***]* X [***]*%) for
a total annual royalty of $[***]*.
PROCTER & XXXXXX PHARMACEUTICALS INC. CHEMOKINE THERAPEUTICS CORP.
____________________________________ ____________________________________
Name: Xxxx Collar Name: Xxxxxx Xxxxxx, Ph.D.
Title: President Title: Chairman & CEO
Global Pharmaceuticals
Date: ______________________________ Date:_______________________________
CTC-PGP Research Agreement
29 June 2004
* PORTIONS OF THIS PAGE HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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